Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30

FDA recall notice · announced June 21, 2023 · Amring Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lots: X220317A and X220318A, exp. date 09/25
Quantity: 48,989 bottles
Status: Terminated
Products in this recall event:
- Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30 (D-0871-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.